Improvements in patient safety have been among the primary concerns of many efforts in today's healthcare industry. Healthcare associated infections remain a major area of focus for these efforts. The Center for Disease Control and Prevention cites healthcare associated infections in the top ten leading causes of death in the United States. Annually, healthcare associated infections account for an estimated 1.7 million infections in hospitals, 99,000 associated deaths, and 4.5 to 5.7 billion dollars in added patient care costs.
The reduction of healthcare associated infections depends upon awareness and adherence to aseptic technique when handling medical equipment that comes into direct contact with a patient. Medical equipment is constantly threatened by exposure to surrounding contaminated surfaces. These surfaces contain microorganisms (bacteria) which can easily adhere to the surface of medical equipment. Once contaminated, the medical equipment becomes a danger to the patient and can serve as a silent killer.
Healthcare institutions use millions of intravenous catheters each year. These catheters are at risk of contamination by a variety of mechanisms. One such mechanism relates to the contamination of the exposed ports of intravenous administration sets. This particular problem arises when an intravenous infusion line is temporarily disconnected from a patient (a process which can occur multiple times per day for an individual patient). During the time that the infusion line is disconnected from the patient, the exposed port of the intravenous line may contact potential contaminants. These contaminants could then lead to infection within a patient's bloodstream.
The critical event in the aforementioned circumstance is the failuer to retain the sterility of the intravenous port(s) and failuer to adequately disinfect the port in the instance of inadvertent contamination during the time of disconnect from infusion tubing. This risk is, in part, an unanticipated outcome of the somewhat recent implementation of needleless intravenous systems.
Currently, many practitioners are not actively considering the risk of contamination and are not taking steps to secure the sterility of exposed ports. When efforts are made to maintain the sterility of exposed ports, these efforts are both cumbersome (and therefore at times skipped over), or they fail due to technical shortcomings.
Safe practice recommendations include the use of aseptic technique when handling medical infusion lines. The current aseptic technique, as pertains specifically to intravenous catheters, includes sterilizing the exposed ports used for intermittent infusions with alcohol prep pads between uses. Disinfecting the surfaces of medical equipment with alcohol is a well accepted and established practice. Evidence exists supporting the use of a one minute alcohol exposure as an adequate disinfecting technique.
Current practice often utilizes alcohol cloth swabs to accomplish the task of disinfecting the surface of medical equipment, including intravenous tubing ports. This method has faults limiting its use. The exposure of the port to the cloth swab of alcohol is often performed in variable fashion. With variable techniques and inadequate exposure times to the disinfectant, successful sterilization is unlikely over the entirety of the surface area on female ports and port valve surfaces. In addition, the current standard disinfecting system of using an alcohol pad exposes the port, to the skin of the practitioner during and immediately after the disinfecting process. Lastly, the alcohol prep pads containing the cloth swabs may not be immediately available for use at the time of greatest need.
The port protection system disclosed in this invention description includes a means to temporarily and safely cover and apply antiseptic to the female end and end internal surfaces of a medical infusion apparatus. In this way, the device and associated method described will adequately provide a means to maintain the sterility of an indwelling intravenous administration set (or other medical infusion line), including any exposed internal valve surface, that has been disconnected from a patient until it is ready to be reattached for future use.
Some tubular medical line ports are needleless access devices which include a valve mechanism. It is an object of the present invention to provide an apparatus for sterilizing such tubular medical line ports, including the exposed valve surfaces, without risking inadvertent activation or depression of the mechanical valve inside the device, as this would open up the IV tubing and fluid pathway towards the patient.